XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors

Inclusion Criteria: * Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach * 18 years or older * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3 * Willing and able to sign informed consent * Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide) * Women of child-bearing age must have a negative pregnancy test * Laboratory criteria Exclusion Criteria: * Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study) * Unstable angina, or class III or IV New York Heart Association heart disease * Central nervous system metastases * Uncontrolled diabetes mellitus * Uncontrolled seizure disorder * Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment * Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation * Pregnant or breast-feeding * A known history of human immunodeficiency virus (HIV) infection